JP2002523137A - Bifurcated catheter assembly - Google Patents

Bifurcated catheter assembly

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Publication number
JP2002523137A
JP2002523137A JP2000565814A JP2000565814A JP2002523137A JP 2002523137 A JP2002523137 A JP 2002523137A JP 2000565814 A JP2000565814 A JP 2000565814A JP 2000565814 A JP2000565814 A JP 2000565814A JP 2002523137 A JP2002523137 A JP 2002523137A
Authority
JP
Japan
Prior art keywords
catheter
bifurcated
branch
guidewire
lumen
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
JP2000565814A
Other languages
Japanese (ja)
Other versions
JP3631139B2 (en
Inventor
ケビン、エム.モーチ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Cardiovascular Systems Inc
Original Assignee
Advanced Cardiocasvular Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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Publication of JP2002523137A publication Critical patent/JP2002523137A/en
Application granted granted Critical
Publication of JP3631139B2 publication Critical patent/JP3631139B2/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

There is described a bifurcated catheter assembly provided for treating bifurcated vessels. The bifurcated catheter assembly comprises an elongate main catheter shaft having a stiffer proximal portion, a more flexible distal portion, and a pair of branch catheters attached to the distal portion. An expandable member is located on each of the branch catheters. The balloons are held together to provide a low profile as the device is advanced over the tracking guide wire. Upon reaching the bifurcated vessel, the balloons separated and are advanced over separate guide wires into separate branches of the bifurcated vessel. The bifurcated catheter assembly can be used to dilate a stenosis or deliver and implant a Y-shaped stent in the bifurcation.

Description

【発明の詳細な説明】DETAILED DESCRIPTION OF THE INVENTION

【0001】[0001]

【発明の属する技術分野】TECHNICAL FIELD OF THE INVENTION

本発明は、全体として、血管の疾病の治療で使用されるバルーンカテーテルに
関する。更に詳細には、本発明は、二つの平行な拡張バルーンが単一のカテーテ
ルシャフトの先端に設けられた二股カテーテルアッセンブリに関する。二股カテ
ーテルアッセンブリは、動脈分岐部を治療するための改良手段を提供する。
The present invention relates generally to balloon catheters used in the treatment of vascular diseases. More particularly, the present invention relates to a bifurcated catheter assembly where two parallel dilatation balloons are provided at the tip of a single catheter shaft. Bifurcated catheter assemblies provide an improved means for treating arterial bifurcations.

【0002】[0002]

【従来の技術】[Prior art]

経皮的血管内腔拡張術(PTCA)として既知の医療的方法では、動脈壁に沿
ってプラクが堆積することにより狭窄し即ち制限されるようになった冠状動脈(
又は他の血管)を、バルーンカテーテルを使用して治療する。PTCA術では、
バルーンカテーテルを経皮的に挿入し、冠状動脈の内腔を通して狭窄箇所まで前
進させる。次いでバルーンを膨張し、プラクを動脈壁に押し付けることによって
動脈の内腔を拡張し、適当な血流を確保する。
In a medical procedure known as percutaneous transluminal vasodilation (PTCA), coronary arteries that become stenotic or restricted by the accumulation of plaque along the arterial wall (
Or other blood vessels) are treated using a balloon catheter. In PTCA surgery,
A balloon catheter is inserted percutaneously and advanced through the lumen of the coronary artery to the stenosis. The balloon is then inflated and the lumen of the artery is dilated by pressing the plaque against the artery wall to ensure proper blood flow.

【0003】 PTCA術を実施した後、再狭窄を阻止し且つ血流用の障害のない通路を維持
するため、ステント(これは、当該技術分野で周知である)を治療領域で拡張す
る。次いでバルーンを一時的に膨張させることにより、ステントを血管内で膨張
し、埋め込む。その後、バルーンを萎ませ、血管壁を支持し且つ再狭窄が起こら
ないようにするため、埋め込んだステントを血管内に残してバルーンカテーテル
アッセンブリを内腔から取り出す。
After performing a PTCA procedure, a stent, which is well known in the art, is expanded at the treatment area to prevent restenosis and maintain an unobstructed passage for blood flow. The stent is then inflated and implanted in the blood vessel by temporarily inflating the balloon. The balloon catheter assembly is then removed from the lumen leaving the implanted stent in the vessel to deflate the balloon, support the vessel wall, and prevent restenosis.

【0004】 疾病状態の多くの動脈は、従来のバルーンカテーテル及びステントを使用して
この方法で十分に治療できるけれども、分岐部に疾病がある動脈は、現在入手可
能な装置では治療が困難である。例えば、PTCA中に従来のバルーンカテーテ
ルを使用して分岐部の血管通路の一方を治療すると、治療した通路内のバルーン
の膨張による圧力により、未治療の通路への血流が制限されてしまう場合がある
。これは、未治療の血管の入口に亘って分岐部を押すことによる。更に、治療し
た通路内のバルーンの圧力によりプラクが治療した通路から未治療の通路に移動
してしまう場合がある。十分な量のプラクが未治療の通路に移動すると、未治療
の通路の入口が塞がれてしまい、未治療の血管でPTCAを実施するためにガイ
ドワイヤ及びカテーテルを挿入することが困難になり、又は不可能になってしま
う。
[0004] While many arteries with disease states can be adequately treated in this manner using conventional balloon catheters and stents, arteries with bifurcation disease are difficult to treat with currently available devices. . For example, if one of the bifurcation vascular passages is treated using a conventional balloon catheter during PTCA, the pressure due to the inflation of the balloon in the treated passage restricts blood flow to the untreated passage. There is. This is by pushing the bifurcation over the entrance to the untreated vessel. In addition, the pressure of the balloon in the treated passage may cause the plaque to move from the treated passage to the untreated passage. As a sufficient amount of plaque moves into the untreated passage, the entrance to the untreated passage becomes blocked, making it difficult to insert guidewires and catheters to perform PTCA on untreated vessels. Or become impossible.

【0005】 更に、ステントを分岐部のところで展開するには、ステントを分岐部の疾病領
域全体に亘って被せなければならず、しかもステント自体が血流を阻害してはな
らないため、非常に困難である。従来のステントは、分岐部から離れた血管の領
域を修復するように設計されており、従来のステントが、一般的には、その長さ
方向軸線に対して直角に終端するため、血管分岐部の領域で従来のステントを使
用すると、側方分枝の血流を閉塞する(一般的に、側方分岐部の「ジェイリング
(jailing)」と呼ばれる)ことになるか或いは、分岐部を必要とされる
程度一杯まで修復することができない。効果的であるためには、ステントを入口
の全周に亘って被せなければならず、疾病部分内及びこれを越えた箇所まで延び
ていなければならない。ステントを入口の全周に亘って疾病部分まで被せていな
い場合には、ステントは分岐した血管を完全に修復することができない。
[0005] Furthermore, deploying a stent at a bifurcation is very difficult because the stent must be covered over the diseased area of the bifurcation, and the stent itself must not impede blood flow. It is. Conventional stents are designed to repair an area of the blood vessel that is remote from the bifurcation, which typically terminates at a right angle to its longitudinal axis, thus resulting in a vascular bifurcation. Use of a conventional stent in the area of the obstruction may occlude blood flow in the side branch (commonly referred to as "jailing" of the side branch) or may require a branch It cannot be repaired to the fullest extent. To be effective, the stent must cover the entire perimeter of the portal and must extend into and beyond the diseased area. If the stent is not covered all the way around the entrance to the diseased part, the stent cannot completely repair the bifurcated blood vessel.

【0006】 従来のステントを使用することに伴う問題点及び制限を解決するため、分岐部
治療用のY字形状ステントが提案されてきた。このようなステントには、分岐部
の他の部分の血流を阻害することなく、分岐部のところで血管を完全に修復する
という利点がある。更に、このようなステントは、治療を施す必要がある分岐血
管の全ての部分にアクセスできる。角をなした大動脈口部血管の始部に疾病があ
る状態では、このようなステントには、口部内に突出したり複雑な繰り返しアク
セスを行わずに血管始部を完全に修復するという利点がある。提案されたY字形
状ステントは、分岐部を修復するための改良装置を提供するが、このようなステ
ントの挿入及び展開は、従来のバルーンカテーテルでは容易に行うことができな
い。
[0006] To overcome the problems and limitations associated with using conventional stents, Y-shaped stents for bifurcation treatment have been proposed. Such a stent has the advantage of completely repairing the blood vessel at the bifurcation without interrupting blood flow elsewhere in the bifurcation. Further, such a stent has access to all parts of the branch vessel that need to be treated. With disease at the beginning of the horned aortic ostium, such stents have the advantage of completely repairing the vascular apex without protruding into the mouth or performing complex, repeated access. . Although the proposed Y-shaped stent provides an improved device for repairing bifurcations, insertion and deployment of such stents is not easily accomplished with conventional balloon catheters.

【0007】 従来のバルーンカテーテルが動脈分岐部の治療に適していないため、多くの医
師は、現在、二つの別々のバルーンカテーテルをガイドカテーテルに挿入し、各
バルーンを別々のガイドワイヤ上で移動する「キッシングバルーン(kissi
ng balloon)」技術を使用している。ガイドカテーテルを分岐箇所の
手前の箇所まで前進した後、二つのガイドワイヤをガイドカテーテルの先端から
別々の血管通路内に前進させる。次いで、二つのバルーンカテーテルをガイドワ
イヤに沿って夫々の通路内に移動する。これらのバルーンを、別々の膨張媒体を
使用して、又は単一の媒体源から流れを分割するマニホールドを使用して、同時
に膨張させる。PTCA又はステント拡張に二つのカテーテルを使用することに
より、両血管通路を分岐部のところで同時に治療できる。
[0007] Because conventional balloon catheters are not suitable for treating arterial bifurcations, many physicians currently insert two separate balloon catheters into a guide catheter and move each balloon over a separate guidewire. "Kissing balloon (kissi)
ng ballon "technology. After advancing the guide catheter to a point just before the bifurcation, the two guide wires are advanced from the distal end of the guide catheter into separate vascular passages. The two balloon catheters are then moved along the guidewire into their respective passages. The balloons are inflated simultaneously using separate inflation media or using a manifold to split flow from a single source of media. By using two catheters for PTCA or stent expansion, both vessel passages can be treated simultaneously at the bifurcation.

【0008】 全体として効果的であるけれども、動脈分岐部の治療に二つの単一のバルーン
カテーテルを使用することには大きな欠点がある。例えば、ガイドカテーテルの
基端から二つの同様のカテーテルが出ているため、医師は、何れのカテーテルが
何れのバルーンを制御するのかについて混乱を生じることなく両装置を管理する
のが困難になる。更に、一つのガイドカテーテル内に二つのバルーンカテーテル
が存在するため、装置のプロファイルが大きくなり、これによって、医師が分岐
部を見ることができるようにするために血管内に注入できる放射線不透過性染料
の量が制限される。
[0008] Although effective overall, there are significant drawbacks to using two single balloon catheters to treat arterial bifurcations. For example, the emergence of two similar catheters from the proximal end of the guide catheter makes it difficult for a physician to manage both devices without causing confusion as to which catheter controls which balloon. In addition, the presence of two balloon catheters within one guide catheter increases the profile of the device, which allows the radiopacity to be injected into a blood vessel so that the physician can see the bifurcation. The amount of dye is limited.

【0009】 特に動脈分岐部の治療用に設計されたバルーンカテーテルを開発するための努
力がなされてきた。このような努力により、カテーテル先端に配置されたY字形
状バルーンが提案された。このバルーンは、両通路を同時に治療するために分岐
部で膨張される。Y字形状バルーンは、二つの別々のバルーンカテーテルを使用
することを上回る改良をもたらすけれども、提案された装置は実際的でない。こ
れは、Y字形状バルーンを製造し、これをカテーテルシャフトに取り付け、血管
分岐部に適正に位置決めするのが困難であるためである。この種の装置は、19
95年10月30日に出願された「動脈分岐部用血管形成装置」という標題の国
際特許出願WO97/16217号に記載されている。
[0009] Efforts have been made to develop balloon catheters specifically designed for the treatment of arterial bifurcations. With these efforts, a Y-shaped balloon placed at the tip of the catheter has been proposed. The balloon is inflated at the bifurcation to treat both passages simultaneously. Although a Y-shaped balloon provides an improvement over using two separate balloon catheters, the proposed device is impractical. This is because it is difficult to manufacture a Y-shaped balloon, attach it to the catheter shaft, and properly position it at the vessel bifurcation. This type of device is
It is described in International Patent Application No. WO 97/16217 entitled "Aortic Bifurcation Angioplasty Device" filed on October 30, 1995.

【0010】[0010]

【発明が解決しようとする課題】[Problems to be solved by the invention]

かくして、PTCA及びステントの送出及び展開の両方で、動脈分岐部の効果
的治療に使用できる改良バルーンカテーテルに対する必要が存在する。更に、こ
のようなバルーンカテーテルは、使用が容易であり、安価に製造でき、今日の産
業で一般的な材料から製造できるのが望ましい。本発明は、この必要を満たそう
とするものである。
Thus, there is a need for an improved balloon catheter that can be used for effective treatment of arterial bifurcations for both delivery and deployment of PTCA and stents. Moreover, such balloon catheters are desirably easy to use, inexpensive to manufacture, and can be made from materials common in today's industry. The present invention seeks to meet this need.

【0011】[0011]

【課題を解決するための手段】[Means for Solving the Problems]

本発明は、分岐部の主血管及び側方分枝血管の両方の狭窄部を同時に拡張する
のに使用できる二股カテーテルアッセンブリを提供し、更に、Y字形状ステント
の送出及び展開を迅速に且つ容易に行うための手段を提供する。本発明は、二つ
の個々の平行なバルーンが先端に設けられた単一のカテーテルシャフトを含む。
平行なバルーンは、分岐部のところで別々のガイドワイヤに従って別々の血管通
路内に移動し、共通の供給源からの膨張媒体によって同時に膨張される。本発明
は、主に冠状動脈で使用するように設計されているが、腎臓動脈、腹大動脈、大
腿動脈、及び頸動脈等の他の血管の治療にも使用できる。
The present invention provides a bifurcated catheter assembly that can be used to simultaneously dilate both stenoses of both the main vessel and the side branch vessels of the bifurcation, and furthermore makes the delivery and deployment of the Y-shaped stent quick and easy. To provide a means for doing so. The present invention includes a single catheter shaft with two individual parallel balloons at the tip.
The parallel balloons travel along separate guidewires at the bifurcation and into separate vascular passageways and are inflated simultaneously by inflation media from a common source. Although the invention is designed primarily for use in the coronary arteries, it can also be used to treat other blood vessels such as the renal, abdominal aorta, femoral, and carotid arteries.

【0012】 本発明の二股カテーテルアッセンブリは、先端部分に三つの内腔が設けられた
カテーテル本体を含む。第1内腔は、バルーンを膨張させたり萎ませたりするの
に使用される加圧膨張媒体用の膨張内腔である。第2内腔は、トラッキングガイ
ドワイヤを収容したガイドワイヤ内腔であり、第3内腔もまた、一体のガイドワ
イヤを収容したガイドワイヤ内腔である。
The bifurcated catheter assembly of the present invention includes a catheter body having three lumens at the distal end. The first lumen is an inflation lumen for a pressurized inflation medium used to inflate and deflate the balloon. The second lumen is a guidewire lumen containing a tracking guidewire, and the third lumen is also a guidewire lumen containing an integral guidewire.

【0013】 二つの平行なカテーテル枝部がカテーテル本体の先端に連結されている。平行
なカテーテル枝部の各々は2つの内腔を有する。一方の内腔は、カテーテル本体
の膨張内腔と連通した膨張内腔であり、他方の内腔はカテーテル本体のガイドワ
イヤ内腔のうちの一方と連通したガイドワイヤ内腔である。バルーン等の膨張可
能な部材が各カテーテル枝部の周囲に配置されている。これらのバルーンは、各
カテーテル枝部の膨張内腔と連通している。各カテーテル枝部の側部に設けられ
た膨張ノッチにより加圧膨張媒体をバルーンに出し入れできる。各カテーテル枝
部のガイドワイヤ内腔は、先端まで全体に亘って延びており、ガイドワイヤを夫
々の枝部から先端方向に出すことができる。
Two parallel catheter branches are connected to the distal end of the catheter body. Each of the parallel catheter branches has two lumens. One lumen is an inflation lumen that communicates with the inflation lumen of the catheter body, and the other lumen is a guidewire lumen that communicates with one of the guidewire lumens of the catheter body. An inflatable member such as a balloon is disposed around each catheter branch. These balloons are in communication with the inflation lumen of each catheter branch. An inflation notch on the side of each catheter branch allows pressurized inflation media to enter and exit the balloon. The guidewire lumen of each catheter branch extends all the way to the distal end so that the guidewire can be advanced distally from each branch.

【0014】 トラッキングガイドワイヤを、主血管を通して前進させ、ガイドワイヤを分岐
部のところで入口を通して側方分枝血管内に前進させる。一方のガイドワイヤを
分岐部の各通路内に前進させた状態で、第1バルーンがトラッキングガイドワイ
ヤに従って主血管通路内に移動し、第2バルーンが一体のガイドワイヤに従って
側方分枝血管通路内に移動するように二股カテーテルアッセンブリを前進させる
A tracking guidewire is advanced through the main vessel and the guidewire is advanced through the entrance at the bifurcation and into the side branch vessel. With one guidewire advanced into each passage of the bifurcation, the first balloon moves into the main vessel passage according to the tracking guidewire, and the second balloon moves into the side branch vessel passage according to the integrated guidewire. The bifurcated catheter assembly is advanced to move to.

【0015】 二股カテーテルアッセンブリは、PTCA及びステントの送出及び埋め込みの
両方を行うために動脈分岐部で使用できる。本発明の他の特徴及び利点は、以下
の詳細な説明を本発明の特徴を例示する添付図面と関連して読むことにより明ら
かになるであろう。
The bifurcated catheter assembly can be used at the arterial bifurcation to both deliver and implant PTCA and stents. Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, illustrating by way of example the features of the invention.

【0016】[0016]

【発明の実施の形態】BEST MODE FOR CARRYING OUT THE INVENTION

本発明は、冠状動脈、静脈、動脈、及び身体の他の血管の分岐部を治療するた
めのアッセンブリ及び方法を含む。図1に示すように、動脈分岐部は、動脈が2
つの血管通路に分かれる身体の脈管系内の場所である。図1は、プラクが動脈の
壁にどのように堆積して狭窄症として周知の狭窄を引き起こすのかを示す。狭窄
症は、PTCAとして周知の手順でバルーンカテーテルを使用してプラクを血管
壁に押し付けることによって拡張できる。PTCAを実施した後、ステントを血
管内で展開し、狭窄症の再発の可能性を小さくする。
The present invention includes assemblies and methods for treating coronary arteries, veins, arteries, and bifurcations of other blood vessels in the body. As shown in FIG. 1, the artery bifurcation is
A location in the body's vascular system that divides into two vascular passages. FIG. 1 shows how plaque deposits on the walls of arteries, causing a stenosis known as stenosis. Stenosis can be dilated by pressing a plaque against the vessel wall using a balloon catheter in a procedure known as PTCA. After performing PTCA, the stent is deployed intravascularly to reduce the likelihood of recurrence of stenosis.

【0017】 動脈分岐部を治療するための従来の技術は、満足のいくものではないというこ
とがわかっている。例えば、図2、図3、及び図4には、動脈分岐部を治療する
ための従来の技術が示してある。これらの技術では、単一のバルーン、二つの単
一のバルーン、及びY字形状バルーンを使用する。図2を参照すると、単一のバ
ルーンカテーテルを分岐部の一方の枝部に挿入し、これを膨張させて狭窄部を拡
張する。単一のバルーンカテーテルを使用して動脈分岐部を治療するには、分岐
部の各血管通路を個々に拡張する必要がある。この方法を使用した場合、治療し
た通路の拡張により未治療の通路の壁を押して未治療の枝部への血流を妨げたり
、プラクを治療した通路から未治療の通路へ移動したりしてしまう。従って、こ
の技術は不適切であり、多くの場合、患者に有害な望ましからぬ結果をもたらす
Conventional techniques for treating arterial bifurcations have proven unsatisfactory. For example, FIGS. 2, 3, and 4 show conventional techniques for treating an arterial bifurcation. These techniques use a single balloon, two single balloons, and a Y-shaped balloon. Referring to FIG. 2, a single balloon catheter is inserted into one of the branches and inflated to dilate the stenosis. The use of a single balloon catheter to treat an arterial bifurcation requires that each vessel passage in the bifurcation be individually dilated. When using this method, the dilation of the treated passage may push the walls of the untreated passage to block blood flow to the untreated branch, or move the plaque from the treated passage to the untreated passage. I will. Thus, this technique is inadequate and often has undesirable consequences that are harmful to the patient.

【0018】 多くの医師が、「キッシングバルーン」技術を使用することによって分岐部の
治療を行うことを試みている。図3を参照すると、この従来技術の装置及び方法
は、二つの別個のバルーンカテーテルを使用し、これらのカテーテルの両方をガ
イドカテーテルに挿入し、別々のガイドワイヤに従って移動する。分岐箇所で血
管通路の各々にバルーンを一つづつ前進させ、これらのバルーンを同時に膨張さ
せて狭窄部を拡張するか或いは、血管を拡張させた後、分岐箇所まで二つの別々
のステントを送出して展開する。しかしながら、実際には、二つの別個の単一の
バルーンカテーテルを使用することは煩わしく、両装置を管理するのは医師にと
って困難である。更に、ガイドカテーテル内に二つのカテーテルシャフトが存在
するため、ガイドカテーテルを通るコントラスト(contrast)即ち対照
識別剤の流れが制限され、これによって医師が被治療領域を見るのが困難になる
[0018] Many physicians have attempted to treat the bifurcation by using a "kissing balloon" technique. Referring to FIG. 3, this prior art device and method uses two separate balloon catheters, both of which are inserted into a guide catheter and moved according to separate guidewires. At the bifurcation, a balloon is advanced into each of the vascular passageways, one at a time, to inflate these balloons simultaneously to dilate the stenosis, or to dilate the vessel before delivering two separate stents to the bifurcation. To expand. However, in practice, the use of two separate single balloon catheters is cumbersome and it is difficult for a physician to manage both devices. Further, the presence of the two catheter shafts within the guide catheter limits the contrast or flow of the control discriminating agent through the guide catheter, which makes it difficult for the physician to see the area to be treated.

【0019】 図4に示すように、別の従来技術の装置は、Y字形状バルーンが先端に設けら
れた単一のカテーテルを含む。この装置は、動脈分岐部を治療するための改良手
段として提案された。従来技術は、Y字形状バルーンを血管の内腔を通して前進
させ、分岐部のところで膨張させて両通路を同時に拡張するか或いはY字形状ス
テントを埋め込むことを開示する。Y字形状バルーンは、キッシングバルーン技
術を上回る改良をもらたすけれども、提案されたY字形状バルーンの実用性は疑
わしい。というのは、製造が困難であり、分岐部のところに(例えばワイヤラッ
ピングを)位置決めして展開することに関連した問題があり、全体に大きいため
である。
As shown in FIG. 4, another prior art device includes a single catheter with a Y-shaped balloon at the tip. This device has been proposed as an improved means for treating arterial bifurcations. The prior art discloses advancing a Y-shaped balloon through the lumen of a blood vessel and inflating it at a bifurcation to expand both passages simultaneously or implant a Y-shaped stent. Although the Y-shaped balloon offers improvements over kissing balloon technology, the utility of the proposed Y-shaped balloon is questionable. This is because it is difficult to manufacture, has problems associated with positioning and deploying (eg, wire wrapping) at the bifurcation, and is generally bulky.

【0020】 図2、図3、及び図4に示す従来技術の動脈分岐部治療方法には様々な欠点が
あり、これらの欠点を本発明により解決する。
The prior art arterial bifurcation treatment methods shown in FIGS. 2, 3 and 4 have various disadvantages, which are overcome by the present invention.

【0021】 図5乃至図10、及び図12を参照すると、本発明の二股カテーテルアッセン
ブリは、平行な二つの別個のバルーンを提供する。これらのバルーンは、動脈分
岐部の別個の通路内に前進させることができ、同時に膨張させて狭窄部を拡張す
るか或いはステントを展開することができる。二股カテーテルアッセンブリ10
は、全体として、第1膨張内腔14及び第1ガイドワイヤ内腔16が貫通した基
端部分12を持つカテーテル本体11を含む。カテーテル本体の基端部分は、好
ましくは、ポリマージャケット(図示せず)によって取り囲まれたステンレス鋼
チューブである。ポリマージャケットは、潤滑性を高める様々な材料で形成でき
、これらの材料には、ポリエチレン、ナイロン、ポリエチルエーテルケトン、及
びコポリエステル−エラストマーが含まれる。膨張装置を取り付けるため、膨張
ハブ21がカテーテル本体の基端部分の基端に配置されている。
Referring to FIGS. 5-10 and 12, the bifurcated catheter assembly of the present invention provides two separate balloons in parallel. These balloons can be advanced into separate passages in the arterial bifurcation and simultaneously inflated to expand the stenosis or deploy the stent. Bifurcated catheter assembly 10
Generally includes a catheter body 11 having a proximal portion 12 through which a first inflation lumen 14 and a first guidewire lumen 16 pass. The proximal portion of the catheter body is preferably a stainless steel tube surrounded by a polymer jacket (not shown). The polymer jacket can be formed of various materials that enhance lubricity, including polyethylene, nylon, polyethyl ether ketone, and copolyester-elastomer. An inflation hub 21 is located at the proximal end of the proximal portion of the catheter body for mounting the inflation device.

【0022】 好ましい実施形態では、二股カテーテルアッセンブリは、当該技術分野で既知
の迅速交換型のアッセンブリである。図5及び図6を参照すると、第1ガイドワ
イヤ内腔16は、カテーテルアッセンブリ10の基端に設けられた第1出口ポー
ト18を含む。一体のガイドワイヤ15が第1出口ポート18の外側から第1ガ
イドワイヤ内腔16内にこの内腔を通って延びる。図7に示すように、第2ガイ
ドワイヤ内腔17は迅速交換型であり、トラッキングガイドワイヤ19を摺動自
在に受け入れるように形成されている。第2ガイドワイヤ内腔17は、第2出口
ポート20のところでカテーテル本体11を出る。
In a preferred embodiment, the bifurcated catheter assembly is a quick-change assembly known in the art. Referring to FIGS. 5 and 6, the first guidewire lumen 16 includes a first outlet port 18 provided at the proximal end of the catheter assembly 10. An integral guidewire 15 extends from outside the first exit port 18 into the first guidewire lumen 16 and through the lumen. As shown in FIG. 7, the second guidewire lumen 17 is of a quick-change type and is formed to slidably receive a tracking guidewire 19. The second guidewire lumen 17 exits the catheter body 11 at the second exit port 20.

【0023】 随意であるが、ガイドワイヤ出口ポート20とバルーン42の直ぐ基端側の位
置との間でスリット13をカテーテル本体11に設けてもよい。これにより、カ
テーテル本体をトラッキングガイドワイヤ19から「引き剥がす」ことができ、
これによりカテーテルの交換が更に便利になる。
Optionally, a slit 13 may be provided in the catheter body 11 between the guidewire outlet port 20 and a position immediately proximal of the balloon 42. Thereby, the catheter body can be "peeled off" from the tracking guide wire 19,
This makes replacement of the catheter more convenient.

【0024】 カテーテル本体11の基端部分12は、カテーテル本体11の先端部分22に
連結されている。カテーテル本体11の先端部分22は、カテーテルの先端部分
での可撓性を高めるため、好ましくは、ポリマー材料から形成されている。カテ
ーテル本体11の先端部分22は、膨張媒体を搬送するための第1膨張内腔14
の延長部、一体のガイドワイヤ15を収容した第1ガイドワイヤ内腔16、及び
トラッキングガイドワイヤ19を収容した第2ガイドワイヤ内腔17を含む。カ
テーテル本体11の基端部分12と先端部分22との間の連結部分30により、
膨張媒体を基端と先端との間で、漏れなく、連続的に流すことができる。
The proximal portion 12 of the catheter body 11 is connected to the distal portion 22 of the catheter body 11. The distal portion 22 of the catheter body 11 is preferably formed from a polymeric material to increase flexibility at the distal portion of the catheter. The distal end portion 22 of the catheter body 11 includes a first inflation lumen 14 for carrying an inflation medium.
, A first guidewire lumen 16 containing an integral guidewire 15, and a second guidewire lumen 17 containing a tracking guidewire 19. By the connecting portion 30 between the proximal portion 12 and the distal portion 22 of the catheter body 11,
The expansion medium can flow continuously between the proximal end and the distal end without leakage.

【0025】 カテーテル枝部32の断面を図8に示す。カテーテル枝部34は、同様の断面
形体を有する。
FIG. 8 shows a cross section of the catheter branch 32. The catheter branch 34 has a similar cross-sectional configuration.

【0026】 カテーテル本体11の先端部分22は、第1及び第2の平行なカテーテル枝部
32及び34に夫々連結されている。カテーテル本体と平行なカテーテル枝部の
各々との間の連結部分36により、膨張媒体を、先端シャフトの第1膨張内腔か
らカテーテル枝部の各々の第2及び第3の膨張内腔37、38まで連続的に流す
ことができる。平行なカテーテル枝部32、34は、夫々、膨張媒体を連通する
ための第2及び第3の膨張内腔37、38、及び一体のガイドワイヤ15及びト
ラッキングガイドワイヤ19を通すための第1及び第2のガイドワイヤ内腔16
、17を含む。第1及び第2のカテーテル枝部は、先端チップ46、48を夫々
有し、これを通ってガイドワイヤがガイドワイヤ内腔を出る。トラッキングガイ
ドワイヤ19は、第1カテーテル枝部32の先端チップ46から出る。一体のガ
イドワイヤ15は第2カテーテル枝部34の先端チップ48から出る。図12に
示すように、第2カテーテル枝部34の先端の側部には短いチューブ形態の連結
装置54が取り付けられている。カテーテルアッセンブリの前進中、トラッキン
グガイドワイヤ19は、第1カテーテル枝部32を出て第2カテーテル枝部34
の連結装置に通され、二つのカテーテル枝部を互いに保持する。
The distal end portion 22 of the catheter body 11 is connected to first and second parallel catheter branches 32 and 34, respectively. A connection 36 between the catheter body and each of the parallel catheter branches allows inflation media to be transferred from the first inflation lumen of the distal shaft to the second and third inflation lumens 37, 38 of each of the catheter branches. Up to continuous flow. The parallel catheter branches 32,34 respectively have second and third inflation lumens 37,38 for communicating the inflation medium, and first and second for passing the integral guidewire 15 and tracking guidewire 19, respectively. Second guidewire lumen 16
, 17 are included. The first and second catheter branches have distal tips 46, 48, respectively, through which the guidewire exits the guidewire lumen. The tracking guidewire 19 exits the distal tip 46 of the first catheter branch 32. The integral guidewire 15 exits the distal tip 48 of the second catheter branch 34. As shown in FIG. 12, a connecting device 54 in the form of a short tube is attached to the side of the distal end of the second catheter branch portion 34. During advancement of the catheter assembly, the tracking guidewire 19 exits the first catheter branch 32 and the second catheter branch 34.
To hold the two catheter branches together.

【0027】 カテーテル枝部32、34の夫々には、好ましくはバルーン42、44の形態
の膨張可能な部材が取り付けられている。バルーンは、ポリエチレン、ポリオレ
フィンコポリマー、ポリエチレンテレフタレート、ナイロン、及びペバックスを
含む多くの様々な材料で形成できる。膨張ハブ21は、加圧膨張流体を受け入れ
、膨張流体を膨張内腔14、37、及び38に供給する。各カテーテル枝部は膨
張ノッチ(ノッチ50及び52の夫々)を含み、これらのノッチにより膨張媒体
をカテーテルから出して膨張可能な部材を膨張させることができる。
Each of the catheter branches 32, 34 is fitted with an inflatable member, preferably in the form of balloons 42, 44. Balloons can be formed from many different materials, including polyethylene, polyolefin copolymers, polyethylene terephthalate, nylon, and Pebax. Inflation hub 21 receives pressurized inflation fluid and supplies inflation fluid to inflation lumens 14, 37, and 38. Each catheter branch includes inflation notches (notches 50 and 52, respectively) that allow the inflation medium to exit the catheter and inflate the inflatable member.

【0028】 好ましい実施形態では、カテーテルの全長は約135cm乃至150cmであ
り、膨張ハブ21と連結部分30との間のカテーテル本体の長さは約125cm
である。カテーテル本体の基端部分は、好ましくは、約0.75mmの直径を有
し、カテーテル本体の基端部分と先端部分との間の連結部分とカテーテル本体の
先端部分と平行なカテーテル枝部の各々との間の連結部分36との間のカテーテ
ル本体の先端部分の直径は約1.5mmである。第1カテーテル枝部32は、好
ましくは長さが約10cmであり、直径が約1mmであり、第2カテーテル枝部
34は、長さが約12cmであり、直径が約1mmである。代表的には、膨張可
能な部材はバルーンであり、冠状動脈を治療するため、好ましくは膨張させたと
きの直径が約1.5mm乃至約4.5mmであり、長さが約20mmである。以
上の寸法は、特定の用途及び治療を受ける身体の内腔に応じて大幅に変化する。
In a preferred embodiment, the overall length of the catheter is between about 135 cm and 150 cm, and the length of the catheter body between the inflation hub 21 and the connection portion 30 is about 125 cm
It is. The proximal portion of the catheter body preferably has a diameter of about 0.75 mm and each of the connection between the proximal and distal portions of the catheter body and the catheter branch parallel to the distal portion of the catheter body. The diameter of the distal end portion of the catheter body between the connecting portion 36 and the connecting portion 36 is about 1.5 mm. The first catheter branch 32 is preferably about 10 cm in length and about 1 mm in diameter, and the second catheter branch 34 is about 12 cm in length and about 1 mm in diameter. Typically, the inflatable member is a balloon, which is preferably about 1.5 mm to about 4.5 mm in diameter when inflated to treat a coronary artery and about 20 mm long. These dimensions will vary widely depending on the particular application and body lumen to be treated.

【0029】 本発明のアッセンブリは、両ガイドワイヤ上での押し易さ(pushabil
ity)及び軌道追従性(trackability)を損なわずに低いプロフ
ァイルで送出されるように形成されている。主カテーテルシャフト11の基端部
分12は、ステンレス鋼製チューブにジャケット材料をネッキングすることによ
って形成できる。次いで、ジャケットを備えたチューブを主カテーテルシャフト
の先端部分22に連結する。ガイドワイヤ内腔16、17及び膨張内腔にマンド
レルを挿入し、融着工程中に熱を加えて基端部分を主カテーテルシャフトの先端
部分に熱融着するときにこれらの内腔が潰れないようにする。連結部分30を冷
却した後、マンドレルを取り除き、カテーテルアッセンブリシャフト全体に亘っ
て延びる連続した漏れのない膨張内腔を残す。
The assembly of the present invention provides pushability over both guidewires.
) and trackability without deteriorating the trackability. The proximal portion 12 of the main catheter shaft 11 can be formed by necking a jacket material on a stainless steel tube. The jacketed tube is then connected to the distal portion 22 of the main catheter shaft. Mandrels are inserted into guidewire lumens 16 and 17 and the inflation lumen, and these lumens do not collapse when heat is applied during the fusion process to thermally fuse the proximal portion to the distal portion of the main catheter shaft. To do. After cooling the connecting portion 30, the mandrel is removed, leaving a continuous leak-free inflation lumen extending across the catheter assembly shaft.

【0030】 平行なカテーテル枝部32及び34の各々は、カテーテルアッセンブリの技術
で標準的であるように形成される。バルーン42及び44は、ヒートシール、接
着剤、レーザー溶接、又は溶媒結合、等の周知の技術を使用して各枝部に取り付
けられているか或いは、カテーテル枝部と同じチューブ材料から一部品として形
成される。次いで、カテーテル枝部をカテーテル本体の先端部分に熱を使用して
連結し、組み立てを完了する。カテーテルの組み立て方法は、利用可能な材料及
び製造者の好みに従って変化させることができる。
Each of the parallel catheter branches 32 and 34 is formed as is standard in catheter assembly technology. Balloons 42 and 44 are attached to each branch using known techniques such as heat sealing, adhesives, laser welding, or solvent bonding, or are formed as one piece from the same tubing material as the catheter branch. Is done. The catheter branch is then connected to the distal end of the catheter body using heat to complete the assembly. The method of assembling the catheter can vary according to the materials available and the preferences of the manufacturer.

【0031】 使用に際して、トラッキングガイドワイヤ19を例えば大腿動脈に経皮的に挿
入し、トラッキングガイドワイヤの先端が分岐部の手前側の主血管通路内にある
ように分岐部まで操作する。トラッキングワイヤ19の基端を連結装置54の短
いチューブに挿入し、トラッキングワイヤ19を両枝部のチップに通す。次いで
、トラッキングワイヤ19の基端をカテーテル枝部32の先端チップ46に挿入
する。これにより、カテーテルをターゲット箇所まで滑らかに中断なく移動でき
る。次いで、二股カテーテルアッセンブリ10を、トラッキングガイドワイヤ上
で、バルーン42及び44が主血管通路内で分岐部の直ぐ手前にくるまで前進さ
せる。本発明は、迅速交換型カテーテルであるため、トラッキングガイドワイヤ
19の一部がカテーテルの外側に配置され、及び従って、アッセンブリの前進中
の摩擦抵抗が非常に僅かである。バルーンを、分岐部を越えて先端方向に前進さ
せるとき、トラッキングガイドワイヤ19の先端が連結装置54から引っ込めら
れることによってバルーンが互いから外れるまで、トラッキングガイドワイヤ1
9を手前に引っ張る。次いで、トラッキングワイヤ19を再び前進させてチップ
46に通し、主血管通路に入れる。次いで、二股カテーテルアッセンブリをトラ
ッキングガイドワイヤに沿って手前側に引っ込め、これによりバルーンを分岐部
の手前に置く。トラッキングガイドワイヤが主血管通路内にある状態で、第2ガ
イドワイヤ内腔17内に収容された一体のガイドワイヤを他方のカテーテル枝部
34の先端チップから側方分枝血管内に前進する。この時点で、各カテーテル枝
部の先端チップからガイドワイヤが一つづつ出ており、分岐部の別の通路に進入
している。これによりトラッキングガイドワイヤが主血管通路内にあり、一体の
ガイドワイヤが側方分枝血管通路内にある。次いで、カテーテルアッセンブリを
ガイドワイヤ上で前進させることにより、各バルーンは、狭窄領域に位置決めさ
れるまで、ガイドワイヤに沿って分岐部の別々の通路内に移動する。
In use, the tracking guide wire 19 is inserted percutaneously into, for example, the femoral artery, and the tracking guide wire is operated to the bifurcation so that the tip of the tracking guide wire is in the main blood vessel passage on the near side of the bifurcation. The proximal end of the tracking wire 19 is inserted into the short tube of the connecting device 54, and the tracking wire 19 is passed through the tips of both branches. Next, the proximal end of the tracking wire 19 is inserted into the distal tip 46 of the catheter branch 32. This allows the catheter to move smoothly to the target location without interruption. The bifurcated catheter assembly 10 is then advanced over the tracking guidewire until the balloons 42 and 44 are just before the bifurcation in the main vessel passageway. Because the present invention is a rapid exchange catheter, a portion of the tracking guidewire 19 is located outside the catheter, and therefore, has very little frictional resistance during advancement of the assembly. When the balloon is advanced distally over the bifurcation, the tracking guidewire 1 is moved until the distal ends of the tracking guidewire 19 are withdrawn from the coupling device 54 so that the balloons are disengaged from each other.
Pull 9 forward. Next, the tracking wire 19 is advanced again, passes through the tip 46, and enters the main vessel passage. The bifurcated catheter assembly is then withdrawn along the tracking guidewire, thereby placing the balloon short of the bifurcation. With the tracking guidewire in the main vessel passageway, the integral guidewire contained in the second guidewire lumen 17 is advanced from the distal tip of the other catheter branch 34 into the side branch vessel. At this point, one guidewire has emerged from the distal tip of each catheter branch, one at a time, and has entered another passage in the bifurcation. This places the tracking guidewire in the main vessel passage and the integral guidewire in the side branch vessel passage. By advancing the catheter assembly over the guidewire, each balloon is moved along the guidewire into a separate passage in the bifurcation until it is positioned in the stenotic region.

【0032】 患者の身体の外側に配置された膨張用注射器(又はポンプ)を膨張ハブ21に
取り付け、加圧膨張媒体を膨張内腔を通してバルーン42及び44に供給する。
図10に示すように、各通路にバルーンを一つづつ置いた状態で、PTCA中に
バルーンを同時に膨張させて狭窄部を拡張できる。分岐部の両通路を同時に治療
するため、通路がPTCAによって挟み潰されたり損傷したりすることがない。
更に、分岐部の全てのプラクが同時に圧縮され、及び従って、プラクが一方の通
路から他方の通路に移動することがない。狭窄領域を拡張した後、バルーンを血
管から容易に引き出すことができるように、バルーンをそれらの最少寸法まで萎
ませる。
An inflation syringe (or pump) located outside the patient's body is attached to inflation hub 21 and pressurized inflation media is supplied to balloons 42 and 44 through the inflation lumen.
As shown in FIG. 10, with one balloon in each passage, the balloon can be simultaneously inflated during PTCA to dilate the stenosis. Since both passages of the bifurcation are treated at the same time, the passages are not pinched or damaged by PTCA.
In addition, all plaque in the branch is compressed at the same time, and therefore, does not move from one passage to the other. After dilating the stenotic area, the balloons are deflated to their minimum dimensions so that the balloon can be easily withdrawn from the blood vessel.

【0033】 添付図面に示す好ましい実施形態では、装置を一体のワイヤ15とともに取り
外すことができ、この際、トラッキングワイヤ19は主血管通路内に残される。
これは、トラッキングワイヤ19がカテーテル本体22を出て、バルーンの先端
から約25cm手前側に配置された出口ポート20を通過する装置の迅速交換形
体により容易になる。
In the preferred embodiment shown in the accompanying drawings, the device can be removed with the integral wire 15, leaving the tracking wire 19 in the main vessel passage.
This is facilitated by the quick-change configuration of the device in which the tracking wire 19 exits the catheter body 22 and passes through an exit port 20 located approximately 25 cm proximal to the tip of the balloon.

【0034】 上文中に言及したスリットを備えた形体により、迅速交換手順が更に容易にな
る。随意であるが、一体のワイヤ15が通過する内腔16を、カテーテル本体の
迅速交換ガイドワイヤ出口ポートに設けることができる。これにより、カテーテ
ル交換中、各ワイヤを夫々の血管内に位置決めした状態に維持できる。更に、随
意であるが、迅速交換を更に容易にするため、内腔16にもスリットを設けるこ
とができる。この場合、基端ハブの先端側に第2ガイドワイヤ出口ポートが設け
られる。
The features with slits mentioned above further facilitate the quick exchange procedure. Optionally, a lumen 16 through which the integral wire 15 passes can be provided in the rapid exchange guidewire exit port of the catheter body. Thus, during catheter exchange, each wire can be maintained in a state of being positioned in each blood vessel. Further, optionally, the lumen 16 may be provided with a slit to further facilitate quick replacement. In this case, a second guidewire exit port is provided on the distal side of the proximal hub.

【0035】 本発明の別の利点は、図11に示すようにY字形状ステントを分岐部に送出し
て埋め込むことができるということである。この手順では、二股カテーテルアッ
センブリ10は、バルーンに取り付けられたY字形状ステント60を有する。バ
ルーン42及び44は、手順中に放射線不透過性染料を血流中に注入できる空間
を提供する低プロファイルを提供するため、送出中、互いに保持される。トラッ
キングガイドワイヤを主血管内に分岐部の向こう側まで前進させる。次いで、二
股カテーテルアッセンブリを、トラッキングガイドワイヤ上でステントが分岐部
の向こう側にあるように、前進させる。次いでトラッキングガイドワイヤを手前
側に引っ込め、これによってバルーンを互いから外す。次いで、トラッキングガ
イドワイヤを主血管内に残した状態でカテーテルアッセンブリを分岐部の手前側
にくるまで手前側に引っ張る。次いで、一体のガイドワイヤを分枝カテーテル3
4の外に、側方分枝血管内に前進させる。カテーテルアッセンブリを、両ガイド
ワイヤ上で、バルーン及びステントが分岐部に固定されるまで前進させる。バル
ーンを膨張させ、ステントを膨張させ、分岐部に埋め込む。
Another advantage of the present invention is that a Y-shaped stent can be delivered and implanted at the bifurcation, as shown in FIG. In this procedure, bifurcated catheter assembly 10 has a Y-shaped stent 60 attached to a balloon. Balloons 42 and 44 are held together during delivery to provide a low profile that provides space for the injection of radiopaque dye into the bloodstream during the procedure. The tracking guidewire is advanced into the main vessel beyond the bifurcation. The bifurcated catheter assembly is then advanced over the tracking guidewire such that the stent is beyond the bifurcation. The tracking guidewires are then retracted forward, thereby releasing the balloons from each other. Next, with the tracking guide wire left in the main blood vessel, the catheter assembly is pulled to the near side until it comes to the near side of the bifurcation. Next, the integral guide wire is connected to the branch catheter 3.
Outside of 4, advance into the side branch vessels. The catheter assembly is advanced over both guidewires until the balloon and stent are secured to the bifurcation. The balloon is inflated, the stent is inflated and implanted in the bifurcation.

【0036】 以上から、本発明の二股カテーテルアッセンブリにより、疾病状態の分岐部の
両通路をPTCA術中に同時に拡張でき、これによって血管に損傷が加わらない
ようにし、プラクが一方の通路から他方の通路まで移行しないようにするという
ことが理解されよう。更に、二股拡張アッセンブリにより、分岐部で使用するた
めの特殊設計のY字形状ステントの送出及び展開が容易になる。本発明は、当該
産業で今日使用されている一般的な材料で製造され、使用が簡単であり、製造が
容易である。
From the above, the bifurcated catheter assembly of the present invention allows both paths of a diseased bifurcation to expand simultaneously during a PTCA procedure, thereby preventing damage to blood vessels and allowing plaque to pass from one path to the other. It will be understood that the transition does not take place. Further, the bifurcated expansion assembly facilitates delivery and deployment of a specially designed Y-shaped stent for use at a bifurcation. The present invention is made of common materials used today in the industry, is simple to use and easy to manufacture.

【0037】 本発明の特定の形態を例示し且つ説明したが、本発明の精神及び範囲から逸脱
することなく、様々な変更を行うことができるということは明らかである。
While particular forms of the invention have been illustrated and described, it will be apparent that various changes can be made without departing from the spirit and scope of the invention.

【図面の簡単な説明】[Brief description of the drawings]

【図1】 疾病状態の動脈分岐部の断面図である。FIG. 1 is a sectional view of an arterial bifurcation in a disease state.

【図2】 主血管の拡張に使用される従来技術の単一バルーンカテーテルを示す動脈分岐
部の断面図である。
FIG. 2 is a cross-sectional view of an arterial bifurcation showing a prior art single balloon catheter used to dilate a main vessel.

【図3】 主血管及び側方分枝血管の両方を同時に拡張するのに使用される従来技術の2
つのバルーンカテーテルを示す動脈分岐部の断面図である。
FIG. 3 illustrates a prior art 2 used to simultaneously dilate both the main vessel and the side branch vessels.
It is sectional drawing of the arterial branch part which shows two balloon catheters.

【図4】 主血管及び側方分枝血管の両方を拡張するのに使用される従来技術のY字形バ
ルーンを示す動脈分岐部の断面図である。
FIG. 4 is a cross-sectional view of an arterial bifurcation showing a prior art Y-shaped balloon used to dilate both the main vessel and the side branch vessels.

【図5】 本発明の実施形態としての二股拡張カテーテルの側面図である。FIG. 5 is a side view of a bifurcated dilatation catheter as an embodiment of the present invention.

【図6】 カテーテル本体の基端部分の図5の6−6線に沿った拡大断面図である。6 is an enlarged cross-sectional view of the proximal end portion of the catheter body taken along line 6-6 in FIG. 5;

【図7】 カテーテル本体の先端部分の図5の7−7線に沿った拡大断面図である。7 is an enlarged sectional view of the distal end portion of the catheter body taken along line 7-7 in FIG. 5;

【図8】 一方のカテーテル枝部の基端部分の図5の8−8線に沿った拡大断面図である
8 is an enlarged cross-sectional view of the proximal end portion of one catheter branch taken along line 8-8 in FIG. 5;

【図9】 一方のカテーテル枝部の先端部分の図5の9−9線に沿った拡大断面図である
9 is an enlarged cross-sectional view of the distal end portion of one of the catheter branches, taken along line 9-9 in FIG. 5;

【図10】 PTCA中に拡張させた両バルーンを示す動脈分岐部の断面図である。FIG. 10 is a cross-sectional view of the arterial bifurcation showing both balloons expanded during PTCA.

【図11】 本発明の展開したステントを示す動脈分岐部の断面図である。FIG. 11 is a cross-sectional view of an arterial bifurcation showing a deployed stent of the present invention.

【図12】 互いに連結されたカテーテル枝部を示す、二股カテーテルアッセンブリの正面
図である。
FIG. 12 is a front view of a bifurcated catheter assembly showing the catheter branches connected together.

【符号の説明】[Explanation of symbols]

10 二股カテーテルアッセンブリ 11 カテーテル本体 12 基端部分 13 スリット 14 第1膨張内腔 16 第1ガイドワイヤ内腔 17 第2ガイドワイヤ内腔 18 第1出口ポート18 19 トラッキングガイドワイヤ 20 第2出口ポート 21 膨張ハブ 22 カテーテル本体 42 バルーン DESCRIPTION OF SYMBOLS 10 Bifurcated catheter assembly 11 Catheter main body 12 Base end part 13 Slit 14 First inflation lumen 16 First guidewire lumen 17 Second guidewire lumen 18 First exit port 18 19 Tracking guidewire 20 Second exit port 21 Inflation Hub 22 catheter body 42 balloon

───────────────────────────────────────────────────── フロントページの続き (81)指定国 EP(AT,BE,CH,CY, DE,DK,ES,FI,FR,GB,GR,IE,I T,LU,MC,NL,PT,SE),OA(BF,BJ ,CF,CG,CI,CM,GA,GN,GW,ML, MR,NE,SN,TD,TG),AP(GH,GM,K E,LS,MW,SD,SL,SZ,UG,ZW),E A(AM,AZ,BY,KG,KZ,MD,RU,TJ ,TM),AE,AL,AM,AT,AU,AZ,BA ,BB,BG,BR,BY,CA,CH,CN,CU, CZ,DE,DK,EE,ES,FI,GB,GD,G E,GH,GM,HR,HU,ID,IL,IN,IS ,JP,KE,KG,KP,KR,KZ,LC,LK, LR,LS,LT,LU,LV,MD,MG,MK,M N,MW,MX,NO,NZ,PL,PT,RO,RU ,SD,SE,SG,SI,SK,SL,TJ,TM, TR,TT,UA,UG,UZ,VN,YU,ZA,Z W Fターム(参考) 4C167 AA07 AA55 AA56 BB02 BB27 BB39 CC09 DD01 GG06 GG07──────────────────────────────────────────────────続 き Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SL, SZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AL, AM, AT, AU, AZ, BA, BB, BG, BR , BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS , JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, UA, UG, UZ, VN, YU, ZA, ZWF term (reference) 4C167 AA07 AA55 AA56 BB02 BB27 BB39 CC09 DD01 GG06 GG07

Claims (6)

【特許請求の範囲】[Claims] 【請求項1】 分岐した血管を治療するための二股カテーテルアッセンブリにおいて、 基端部分及び先端部分、第1膨張内腔、第1ガイドワイヤ内腔、及び第2ガイ
ドワイヤ内腔を持つ細長いカテーテル本体、 前記カテーテル本体の前記先端部分に連結された第1カテーテル枝部であって
、前記カテーテル本体の前記第1膨張内腔と流体連通した第2膨張内腔を有し、
前記第1ガイドワイヤ内腔が延びており且つ前記カテーテル本体内の前記第1ガ
イドワイヤ内腔と連通している、第1カテーテル枝部、 前記カテーテル本体の前記先端部分に連結された第2カテーテル枝部であって
、前記第1膨張内腔と流体連通した第3膨張内腔を有し、前記第2ガイドワイヤ
内腔が延びており且つ前記カテーテル本体の前記第2ガイドワイヤ内腔と連通し
ている、第2カテーテル枝部、 前記第1カテーテル枝部と関連し、前記第2膨張内腔と流体連通した第1膨張
可能部材、及び 前記第2カテーテル枝部と関連し、前記第3膨張内腔と流体連通した第2膨張
可能部材を有し、 前記第1及び第2膨張可能部材は、前記第1及び第2膨張可能部材を同時に膨
張させて狭窄部を拡張し、主血管及び側方分枝血管の開存性を回復するように、
主血管内及び側方分枝血管内の夫々の狭窄部にわたって配置される、二股カテー
テルアッセンブリ。
1. A bifurcated catheter assembly for treating a bifurcated blood vessel, wherein the catheter body has a proximal portion and a distal portion, a first inflation lumen, a first guidewire lumen, and a second guidewire lumen. A first catheter branch coupled to the distal end portion of the catheter body, the catheter branch having a second inflation lumen in fluid communication with the first inflation lumen of the catheter body;
A first catheter branch, wherein the first guidewire lumen extends and communicates with the first guidewire lumen in the catheter body; a second catheter connected to the distal end portion of the catheter body. A branch having a third inflation lumen in fluid communication with the first inflation lumen, wherein the second guidewire lumen extends and communicates with the second guidewire lumen of the catheter body. A first inflatable member associated with the first catheter branch and in fluid communication with the second inflation lumen; and a third inflatable member associated with the second catheter branch. A second inflatable member in fluid communication with an inflation lumen, wherein the first and second inflatable members simultaneously inflate the first and second inflatable members to expand a stenosis, Restores patency of lateral branch vessels As
A bifurcated catheter assembly disposed over a respective stenosis in a main vessel and a side branch vessel.
【請求項2】 前記第1及び第2膨張可能部材はバルーンである、請求項1に記載の二股カテ
ーテルアッセンブリ。
2. The bifurcated catheter assembly according to claim 1, wherein said first and second inflatable members are balloons.
【請求項3】 前記第1、第2、及び第3膨張内腔は、加圧流体を前記第1及び第2膨張可能
部材に通す、請求項1に記載の二股カテーテルアッセンブリ。
3. The bifurcated catheter assembly of claim 1, wherein said first, second, and third inflation lumens pass pressurized fluid through said first and second inflatable members.
【請求項4】 前記カテーテル本体は、前記第2カテーテル枝部の先端に連結するための連結
器を前記第1カテーテル枝部の先端に有する、請求項1に記載の二股カテーテル
アッセンブリ。
4. The bifurcated catheter assembly according to claim 1, wherein the catheter body has a connector at the distal end of the first catheter branch for connecting to the distal end of the second catheter branch.
【請求項5】 前記二股カテーテルアッセンブリは、前記第1ガイドワイヤ内腔内に摺動自在
に受け入れられた一体のガイドワイヤ及び前記第2ガイドワイヤ内腔内に摺動自
在に受け入れられたトラッキングガイドワイヤを含む、請求項1に記載の二股カ
テーテルアッセンブリ。
5. The bifurcated catheter assembly includes an integrated guidewire slidably received within the first guidewire lumen and a tracking guide slidably received within the second guidewire lumen. The bifurcated catheter assembly according to claim 1, comprising a wire.
【請求項6】 前記第1及び第2の枝部は、前記カテーテル本体に動かないように連結されて
いる、請求項1に記載の二股カテーテルアッセンブリ。
6. The bifurcated catheter assembly according to claim 1, wherein the first and second branches are fixedly connected to the catheter body.
JP2000565814A 1998-08-24 1999-08-24 Bifurcated catheter assembly Expired - Fee Related JP3631139B2 (en)

Applications Claiming Priority (3)

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US09/138,844 US6117117A (en) 1998-08-24 1998-08-24 Bifurcated catheter assembly
US09/138,844 1998-08-24
PCT/US1999/019127 WO2000010489A1 (en) 1998-08-24 1999-08-24 Bifurcated catheter assembly

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JP2002523137A true JP2002523137A (en) 2002-07-30
JP3631139B2 JP3631139B2 (en) 2005-03-23

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Country Link
US (6) US6117117A (en)
EP (2) EP1107709B1 (en)
JP (1) JP3631139B2 (en)
AT (1) ATE284181T1 (en)
AU (1) AU5579499A (en)
CA (1) CA2338833C (en)
DE (1) DE69922513T2 (en)
WO (1) WO2000010489A1 (en)

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